- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04114201
Clinical Outcome and OR Resource Use of Total Knee Arthroplasty Using Patient-Specific or Conventional Instrumentation (TKA PSI)
Evaluation of Zimmer® Patient Specific Instrumentation vs. Conventional Instrumentation in Total Knee Arthroplasty Procedures: Clinical and Economic Outcomes
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The aim of this study was to compare OR resource use and clinical Outcome after Total Knee Arthroplasty (TKA) using Patient-specific (PSI) or conventional Instrumentation.
For this purpose, economic variables of the surgery (number of instrument trays, setup and cut-sew-time), radiological alignment and patient reported outcomes (VAS Pain Scale, Oxford Knee Score, EQ-5D) were assessed. Cost per QALY (quality-adjusted life year) was assessed using the German DRG reimbursement and the EQ-5D.
A total of 139 TKA with PSI or conventional instrumentation were included in three Centers and were assessed before surgery, as well as 6 weeks, 6 and 12 months postoperatively.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Hesse
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Lorsch, Hesse, Tyskland, 64653
- Department for Orthopaedic and Trauma Surgery, Schön Klinik Lorsch
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Lower Saxony
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Nienburg, Lower Saxony, Tyskland, 31582
- Department for Orthopaedic and Trauma Surgery, Helios Kliniken Mittelweser
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Saxony
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Dresden, Saxony, Tyskland, 01307
- University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Painful, disabled knee joint resulting from osteoarthritis requiring primary TKA
- Informed Consent: Patient has signed a "Patient Informed Consent.
- Able and willing to undergo a preoperative MRI scan (for PSI cases) and full-leg, standing radiographs (all cases)
- Able and willing to follow instructions and complete follow-up
- Patient receiving Zimmer NexGen Solutions CR-Flex (including Gender Solutions)
Exclusion Criteria:
- Patient is skeletally immature
- Active Infection (including septic knee, distant infection, or osteomyelitis)
- Severe hip arthrosis
- Neurological disorders (including, but not limited to Parkinson's disease)
- Prior unicompartmental knee arthroplasty, TKA, knee fusion or patellectomy
- Hip or knee ankylosis
- Either rheumatoid or post-traumatic knee arthritis
- Scheduled for simultaneous bilateral TKA
- Indications of intra- and/or extra-articular deformations that would inhibit the use of PSI guides
- Any metal within 150 mm of the joint line for the operative-side knee
- Knee deformities greater than 15 degrees of fixed varus, valgus, or flexion contracture on initial physical examination
- An existing condition that would, in the opinion of the investigator, compromise participation or follow-up in this study
- A female who is pregnant or lactating
- Current involvement in any personal injury litigation, medical-legal or worker's compensation claims
- Arterial disease or stents that would exclude the use of a tourniquet
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: PSI
Patients received TKA using patient-specific Instrumentation.
|
Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
|
Aktiv komparator: Conventional
Patients received TKA conventional Instrumentation.
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Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
OR time
Tidsramme: during surgery
|
Operating Room (OR) time: incision to Close in minutes
|
during surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
OR resource use: number of instrument trays
Tidsramme: during surgery
|
OR Efficiency measured by number of instrument trays used
|
during surgery
|
OR Setup Time
Tidsramme: during surgery
|
Operating Room (OR) Setup Time in minutes
|
during surgery
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Oxford Knee Score
Tidsramme: 1 year after surgery
|
clinical outcome measured by the Oxford Knee Scoring System.
The Oxford Knee Score is aggregated to a single score where 0 is the worst and 48 is the best Outcome.
|
1 year after surgery
|
visual analog scale (VAS)
Tidsramme: 1 year after surgery
|
patient-reported pain scores as measured by the visual analog scale (VAS), ranging from 0 (worst) to 10 (best).
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1 year after surgery
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device alignment
Tidsramme: 1 year after surgery
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device alignment as determined using radiographs (A/P long-standing and lateral films)
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1 year after surgery
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EQ-5D-3L
Tidsramme: 1 year after surgery
|
patients' health-related Quality of life is measured by the EQ-5D-3L, which aggregates to a single index where 0 is the worst and 1 is the best outcome
|
1 year after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TKA-PSI
Plan for individuelle deltakerdata (IPD)
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